Medical device licence · 65361 · Class 2
BIOSACA SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed August 6, 2004; ended October 17, 2005. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 65361
- Licence holder
- Ortivus AbDanderyd, Sweden
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- August 6, 2004
- Ended
- October 17, 2005
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BIOSACA SYSTEM - AIRFLOW THERMISTOR
- BIOSACA SYSTEM - HEADBOX
- BIOSACA SYSTEM - MAIN UNIT
- BIOSACA SYSTEM - MICROPHONE SENSOR
- BIOSACA SYSTEM - PC SOFTWARE
- BIOSACA SYSTEM - PULSE OXIMETERS
- BIOSACA SYSTEM - SENSOR PAD
- BIOSACA SYSTEM - UPGRADES
- BIOSACA SYSTEM - WITH VARIOUS CHANNELS ENABLED
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.